Caretolive v. Von Eschenbach

• Citation: 525 F.Supp.2d 952
• Decision Date: 04 December 2007
• Docket Number: No. 2:07-cv-729.,2:07-cv-729.
• Parties: CARETOLIVE, Plaintiff, v. Andrew von ESCHENBACH, et al., Defendants.
• Court: United States District Courts. 6th Circuit. United States District Courts. 6th Circuit. Southern District of Ohio

525 F.Supp.2d 952

CARETOLIVE, Plaintiff, v. Andrew von ESCHENBACH, et al., Defendants.

No. 2:07-cv-729.

United States District Court, S.D. Ohio, Eastern Division.

December 4, 2007.

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Kerry M. Donahue, Bellinger & Donahue, Dublin, OH, for Plaintiff.

Mark Thomas D'Alessandro, John J. Stark, United States Attorney's Office, Columbus, OH, Andrew Clark, Daniel K. Crane-Hirsch, Office of Consumer Litigation, U.S. Department of Justice, Washington, DC, for Defendants.

OPINION AND ORDER

GREGORY L. FROST, District Judge.

This action involves a biologics license application ("B LA") that was submitted to the Food and Drug Administration ("FDA") for Provenge, a biological product which is intended to treat a particular type of metastatic prostate cancer and is manufactured by Dendreon Corporation. Plaintiff CareToLive challenges the decision of the FDA "not to approve Provenge for immediate use and instead [to] issue[] a Complete Response Letter requesting more data." (Doc. # 22.)

This matter is before the Court on Plaintiff's Motion for Order that the FDA Comply with. Freedom of Information Act ("Plaintiff's Motion for an Order to Comply") (Doc. # 29), the Motion to. Dismiss Defendants Richard Pazdur, M.D. and Howard Scher, M.D. ("Defendants' Motion to Dismiss") (Doc. # 37), Plaintiff's Motion for Leave to File a Second Amended Complaint (Doc. # 48), and Plaintiff's Motion to Strike Defendants' Reply to Plaintiff's Memorandum Contra Individual Defendant's Motion to Dismiss ("Plaintiff's Motion to Strike") (Doc. # 60). For the reasons set forth below, the Court DENIES all three of Plaintiff's motions and GRANTS Defendants' motion.

I. BACKGROUND

A. The Parties

Plaintiff characterizes itself as an association of "cancer patients, patient families, doctors, investors, and advocates." (Doc. # 22 at 2.) Plaintiff brought this action against the Commissioner of the FDA Andrew von Eschenbach, M.D., and the' Secretary of the United States Department of Health and Human Services Michael Leavitt, in their official capacities and against Richard Pazdur, M.D. and Howard Scher, M.D., in both their official and individual capacities. Id. ¶¶ 4, 5, 6, 7. Pazdur is the Director of the Office of Oncologic Drug Products in the FDA's Center for Drug Evaluation and. Research. Id. ¶ 6. Scher is a special government employee who served on the FDA Advisory Committee that considered the Provenge BLA. Id. ¶ 7..

Defendants filed a separate motion to dismiss the claims against von Eschenbach, Leavitt, Pazdur and Scher in their official capacities. (Doc. # 38.) This Court granted Defendants' motion by separate Opinion and Order.¹ (Doc. # 64.)

B. Statutory and Regulatory Scheme

Biological products are defined under the Public Health Service Act ("PHSA") as any "virus, therapeutic serum, toxin, antitoxin, vaccine ... or analogous product ... applicable to the prevention, treatment, or cure of a disease or condition of human beings." 42 U.S.C. § 262(i). Biological products can also be drugs, and are generally subject to the same statutory and regulatory requirements that apply to drugs. See 42 U.S.C. § 262(j) (the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 321, applies to biological products subject to regulation under the PHSA, 42 U.S.C. § 262).

1. Biological Product Approval Process

For unapproved biological products, the product's sponsor seeks FDA approval by submitting a BLA pursuant to the PHSA. 42 U.S.C. § 262(a). The FDA will approve a BLA for an unapproved biological product if the BLA demonstrates that the product is safe, pure, and potent, id. § 262(a)(2)(C)(i)(I), and that the facility in which the product is manufactured "meets standards designed to assure that the biological product continues to be safe, pure, and potent," id. § 262(a)(2)(C)(i)(II).

Generally, when the sponsor of a biological product has completed the clinical trial process, it can submit a BLA in accordance with 21 C.F.R. § 601.2(a). The required documentation in a BLA provides information for the FDA evaluation of the biological product, including the results of clinical trials, the composition of the drug, manufacturing information, and sample labeling. Id.

2. FDA Responses to a BLA

In response to a BLA, the FDA may refuse to file it if it is incomplete. See FDA, "Refusal to File Procedure for Biologics License Applications," SOPP 8404, available at httpillwww.fda. gov/cber/regsopp/8404.htm. Under certain circumstances, the FDA will approve a BLA, 21 C.F.R. § 601.4(a), or deny it and provide the applicant the opportunity for a hearing, id. § 601.4(b). Finally, if there are deficiencies in the BLA, the FDA may send a Complete Response Letter declining to approve the BLA as it was present ed and requesting additional information from the sponsor. Applications for Approval to Market a New Drug, 69 Fed. Reg. 43351, 43352 (July 20, 2004) (codified at 21 C.F.R. §§ 314.110, 314.120).

C. Statement of Facts

Provenge is a biological product intended to treat a particular type of metastatic prostate cancer. (Doc. # 22 ¶ 15.) Provenge uses a patient's own cells to prepare a final product designed for infusion back into the patient's bloodstream to activate his or her immune system against the cancer cells. Id ¶ 14, 16. Provenge is referred to as an active cellular immunotherapy, designed to elicit a patient's specific immune response to a target antigen expressed in prostate cancer tissue, i.e., to train a patient's immune system to recognize cancer cells and to fight them. Id. ¶¶ 14-16, 19. Because it is designed to act in this manner, Provenge is a vaccine and thus a "biological product" subject to FDA regulation under the PHSA. 42 U.S.C. § 262(i).

Dendreon Corporation has been studying Provenge's safety and effectiveness in clinical trials pursuant to an investigational new drug application it submitted to the FDA in 1996: See Transcript of March 29, 2007 Cellular, Tissue, and Gene Therapies Advisory Committee Meeting at 20; (Doc. # 23, Ex. C.) Dendreon submitted its BLA for Provenge in late 2006, and the FDA considered it to be filed in January 2007. (Doc. # 22 ¶ 27.) Because Provenge is an immunotherapy vaccine, regulatory responsibility for reviewing and, ultimately, approving or denying approval of the BLA rests with the Office of Cellular, Tissue, and Gene Therapies in the FDA Center for Biologics Research and Evaluation. Id. ¶ 29; 68 Fed.Reg. 38067, 38068 (June 26, 2003).

In the Amended Complaint, Plaintiff claims that Pazdur intentionally violated "Federal Regulations and U.S. Law by improperly controlling the makeup of the FDA [Office of Cellular, Tissue, and Gene Therapies] Advisory Committee, and applying improper pressure on Committee members" in an effort to deny due process for the. BLA for Provenge; by purposely placing on the Advisory Committee two oncologists who had conflicts of interest and who Pazdur was sure would be opposed to the approval of Provenge; by, prior to the vote, changing the question posed to the Advisory Committee to get it to recommend against approval of Provenge; by "recruit[ing] and illegally us[ing] FDA employees" at and after the Advisory. Committee meeting to assist him in "wrecking" the Provenge BLA by requesting anti-Provenge letters and "design[ing] a method for `leaking' them to the press." (Doc. # 22 ¶¶ 6, 50, 62, 63, 67, 70, 71, 72, 73, 77, 79.)

Further, Plaintiff alleges that Scher "fail[ed] to disclose conflicts of interest that would have placed the FDA on notice that his own personal interests provided him additional reasons" to be opposed to the immediate approval of the Provenge BLA; wrote a letter attacking Provenge that contained false information and that was later "leaked to the press"; and failed to exercise care in the responsibility he undertook to aid patients. Id. ¶¶ 17, 60, 70, 72, 77, 79.

On May 8, 2007, the Office of Cellular, Tissue, and Gene Therapies in the FDA Center for Biologics Research and Evaluation issued a Complete Response Letter to Dendreon, Provenge's sponsor, declining to approve the BLA in its current form because of various deficiencies. See Dendreon. Corp., "Dendreon Receives Complete Response Letter from FDA for Provenge Biologics License Application," May 9, 2007, available at http:// investor. dendreon. com/ReleaseDetail.cfm?ReleaseID=241649 & Header=News ("Dendreon Receives Complete Response Letter"). The FDA requested that Dendreon submit additional information with respect to the chemistry, manufacturing, and controls section of the BLA so that it could be determined if the facility in which the product would be manufactured "meets standards designed to assure that the biological product continues to be safe, pure, and potent." 42 U.S.C. § 262(a)(2)(C)(i)(II). The FDA also requested that Dendreon submit additional clinical data in support of its effectiveness claim. Dendreon Receives Complete Response Letter. Dendreon has since met with the FDA to discuss the additional data required, to support licensure and indicated that it, intends to proceed with its new Phase 3 study, designed to measure survival and to submit such data to the FDA when it becomes available. See Dendreon Corp., "Dendreon Announces FDA Confirms Data Required for Provenge Licensure," May 31, 2007, available at http:// investor.dendreon.com/Release-Detail.cfm?ReleaselD=246500 & Header = News.

On July 26, 2007, Plaintiff submitted a citizen petition to the FDA. (Doc. # 2 Ex. B.) The FDA's Docket Branch received the citizen petition on July 27, 2007 and assigned it docket number 2007P-0297. Id. Under FDA regulations, a citizen petition is the mechanism for formally asking the agency to take a particular action, and is a prerequisite to filing suit on the subject. See 21 C.F.R. §§ 10.25, 10.30, 10.45. In its citizen petition, Plaintiff urges the Commissioner of the FDA to "reverse [the FDA's] decision to...